Effects of cinacalcet on fracture events in patients receiving hemodialysis: The EVOLVE trial

Journal of the American Society of Nephrology

Volumn 26, Issue 6, 2015, Pages 1466-1475

  Moe, Sharon M ^a   Abdalla, Safa ^b   Chertow, Glenn M ^b   Parfrey, Patrick S ^c   Block, Geoffrey A ^d   Correa Rotter, Ricardo ^e   Floege, Jürgen ^f   Herzog, Charles A ^g   London, Gerard M ^h   Mahaffey, Kenneth W ^b   Wheeler, David C ⁱ   Dehmel, Bastian ^j   Goodman, William G ^j   Drüeke, Tilman B ^k  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Health Sciences Centre St John's   (Canada)

^d Denver Nephrology   (United States)

^e INSTITUTO NACIONAL DE CIENCIAS MÉDICAS Y NUTRICIÓN SALVADOR ZUBIRÁN   (Mexico)

^f UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

^g UNIVERSITY OF MINNESOTA   (United States)

^h Medicine Department   (France)

ⁱ UNIVERSITY COLLEGE LONDON   (United Kingdom)

^j AMGEN INC   (United States)

^k UNIVERSITÉ DE PICARDIE JULES VERNE   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CINACALCET; PLACEBO; NAPHTHALENE DERIVATIVE;

ADULT; ANGINA PECTORIS; ARTICLE; BONE FRAGILITY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CONTROLLED STUDY; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG WITHDRAWAL; END STAGE RENAL DISEASE; FEMALE; FRACTURE; HEART FAILURE; HEMODIALYSIS; HEMODIALYSIS PATIENT; HOSPITALIZATION; HUMAN; INTENTION TO TREAT ANALYSIS; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; PARATHYROIDECTOMY; PERIPHERAL VASCULAR DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SECONDARY HYPERPARATHYROIDISM; TREATMENT DURATION; ADVERSE EFFECTS; AGE; AGED; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ADMINISTRATION; FOLLOW UP; FRACTURES, BONE; HYPERPARATHYROIDISM, SECONDARY; INCIDENCE; KIDNEY FAILURE, CHRONIC; MIDDLE AGED; NONPARAMETRIC TEST; PATHOPHYSIOLOGY; PROCEDURES; PROPORTIONAL HAZARDS MODEL; REFERENCE VALUE; RENAL REPLACEMENT THERAPY; RISK ASSESSMENT; SEX DIFFERENCE; TREATMENT OUTCOME;

ADULT; AGE FACTORS; AGED; CINACALCET HYDROCHLORIDE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; FRACTURES, BONE; HUMANS; HYPERPARATHYROIDISM, SECONDARY; INCIDENCE; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; NAPHTHALENES; PROPORTIONAL HAZARDS MODELS; REFERENCE VALUES; RENAL DIALYSIS; RISK ASSESSMENT; SEX FACTORS; STATISTICS, NONPARAMETRIC; TREATMENT OUTCOME;

EID: 84930442261     PISSN: 10466673     EISSN: 15333450     Source Type: Journal    
DOI: 10.1681/ASN.2014040414     Document Type: Article

References (49)

1. Nickolas TL, McMahon DJ, Shane E: Relationship between moderate to severe kidney disease and hip fracture in the United States. J Am Soc Nephrol 17: 3223-3232, 2006
2. Kaji H, Suzuki M, Yano S, Sugimoto T, Chihara K, Hattori S, Sekita K: Risk factors for hip fracture in hemodialysis patients. Am J Nephrol 22:325-331, 2002
3. Jadoul M, Albert JM, Akiba T, Akizawa T, Arab L, Bragg-Gresham JL, Mason N, Prutz KG, Young EW, Pisoni RL: Incidence and risk factors for hip or other bone fractures among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study. Kidney Int 70: 1358-1366, 2006
4. Tentori F, McCullough K, Kilpatrick RD, Bradbury BD, Robinson BM, Kerr PG, Pisoni RL: High rates of death and hospitalization follow bone fracture among hemodialysis patients. Kidney Int 85: 166-173, 2014
5. Maravic M, Ostertag A, Torres PU, Cohen-Solal M: Incidence and risk factors for hip fractures in dialysis patients. Osteoporos Int 2013
6. Wakasugi M, Kazama JJ, Taniguchi M, Wada A, Iseki K, Tsubakihara Y, Narita I: Increased risk of hip fracture among Japanese hemodialysis patients. J Bone Miner Metab 31: 315-321, 2013
7. Kidney Disease Improving Global Outcomes: Clinical practice guidelines for the management of CKD-MBD. Kidney Int 76: S1-S130, 2009
8. Nickolas TL, Leonard MB, Shane E: Chronic kidney disease and bone fracture: A growing concern. Kidney Int 74: 721-731, 2008
9. Naylor KL, McArthur E, Leslie WD, Fraser LA, Jamal SA, Cadarette SM, Pouget JG, Lok CE, Hodsman AB, Adachi JD, Garg AX: The three-year incidence of fracture in chronic kidney disease [published online ahead of print January 15, 2014]. Kidney Int doi:10.1038/ki.2013.547
10. Alem AM, Sherrard DJ, Gillen DL, Weiss NS, Beresford SA, Heckbert SR, Wong C, Stehman-Breen C: Increased risk of hip fracture among patients with end-stage renal disease. Kidney Int 58: 396-399, 2000
11. Nickolas TL, Cremers S, Zhang A, Thomas V, Stein E, Cohen A, Chauncey R, Nikkel L, Yin MT, Liu XS, Boutroy S, Staron RB, Leonard MB, McMahon DJ, Dworakowski E, Shane E: Discriminants of prevalent fractures in chronic kidney disease. J Am Soc Nephrol 22: 1560-1572, 2011
12. Iimori S, Mori Y, Akita W, Kuyama T, Takada S, Asai T, Kuwahara M, Sasaki S, Tsukamoto Y: Diagnostic usefulness of bone mineral density and biochemical markers of bone turnover in predicting fracture in CKD stage 5D patients - a single-center cohort study. Nephrol Dial Transplant 27: 345-351, 2012
13. Jamal SA, Leiter RE, Jassal V, Hamilton CJ, Bauer DC: Impaired muscle strength is associated with fractures in hemodialysis patients. Osteoporos Int 17: 1390-1397, 2006
14. West SL, Jamal SA, Lok CE: Tests of neuromuscular function are associated with fractures in patients with chronic kidney disease. Nephrol Dial Transplant 27: 2384-2388, 2012
15. Wagner J, Jhaveri KD, Rosen L, Sunday S, Mathew AT, Fishbane S: Increased bone fractures among elderly United States hemodialysis patients. Nephrol Dial Transplant 29: 146-151, 2014
16. Nair SS, Mitani AA, Goldstein BA, Chertow GM, Lowenberg DW, Winkelmayer WC: Temporal trends in the incidence, treatment, and outcomes of hip fracture in older patients initiating dialysis in the United States. Clin J Am Soc Nephrol 8: 1336-1342, 2013
17. Beaubrun AC, Kilpatrick RD, Freburger JK, Bradbury BD, Wang L, Brookhart MA: Temporal trends in fracture rates and postdischarge outcomes among hemodialysis patients. J Am Soc Nephrol 24: 1461-1469, 2013
18. Arneson TJ, Li S, Liu J, Kilpatrick RD, Newsome BB, St Peter WL: Trends in hip fracture rates in US hemodialysis patients, 1993-2010. Am J Kidney Dis 62: 747-754, 2013
19. Gibrat C, Bousquet M, Saint-Pierre M, Lévesque D, Calon F, Rouillard C, Cicchetti F: Cystamine prevents MPTP-induced toxicity in young adult mice via the up-regulation of the brain-derived neurotrophic factor. Prog Neuropsychopharmacol Biol Psychiatry 34: 193-203, 2010
20. Chertow GM, Correa-Rotter R, Block GA, Drueke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Wheeler DC, Parfrey PS: Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial. Nephrol Dial Transplant 27: 2872-2879, 2012
21. Chertow GM, Pupim LB, Block GA, Correa-Rotter R, Drueke TB, Floege J, Goodman WG, London GM, Mahaffey KW, Moe SM, Wheeler DC, Albizem M, Olson K, Klassen P, Parfrey P: Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE): Rationale and design overview. Clin J Am Soc Nephrol 2: 898-905, 2007
22. Chertow GM, Block GA, Correa-Rotter R, Drueke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix CH, Moe SM, Trotman ML, Wheeler DC, Parfrey PS: A randomized trial of cinacalcet in patients on hemodialysis with secondary hyperparathyroidism. N Engl J Med 367: 2482-2494 2012
23. Parfrey PS, Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Herzog CA, London GM, Mahaffey KW, Moe SM, Wheeler DC, Dehmel B, Trotman ML, Modafferi DM, Goodman WG: The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: The EVOLVE trial. J Clin Endocrinol Metab 98: 4834-4844, 2013
24. Chertow GM, Parfrey PS: Cinacalcet for cardiovascular disease in patients undergoing dialysis. N Engl J Med 368: 1844-1845, 2013
25. Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, Segal M, Genant HK, Cummings SR: The association of radiographically detected vertebral fractures with back pain and function: A prospective study. Ann Intern Med 128: 793-800, 1998
26. Atsumi K, Kushida K, Yamazaki K, Shimizu S, Ohmura A, Inoue T: Risk factors for vertebral fractures in renal osteodystrophy. Am J Kidney Dis 33: 287-293, 1999
27. Mares J, Ohlidalova K, Opatrna S, Ferda J: Determinants of prevalent vertebral fractures and progressive bone loss in long-term hemodialysis patients. J Bone Miner Metab 27: 217-223, 2009
28. Villella VR, Esposito S, Maiuri MC, Raia V, Kroemer G, Maiuri L: Towards a rational combination therapy of cystic fibrosis: How cystamine restores the stability of mutant CFTR. Autophagy 9: 1431-1434, 2013
29. Coco M, Rush H: Increased incidence of hip fractures in dialysis patients with low serum parathyroid hormone. Am J Kidney Dis 36: 1115-1121, 2000
30. Danese MD, Kim J, Doan QV, Dylan M, Griffiths R, Chertow GM: PTH and the risks for hip, vertebral, and pelvic fractures among patients on dialysis. Am J Kidney Dis 47: 149-156, 2006
31. Rudser KD, de Boer IH, Dooley A, Young B, Kestenbaum B: Fracture risk after parathyroidectomy among chronic hemodialysis patients. J Am Soc Nephrol 18: 2401-2407, 2007
32. Garrett G, Sardiwal S, Lamb EJ, Goldsmith DJ: PTH - a particularly tricky hormone: Why measure it at all in kidney patients? Clin J Am Soc Nephrol 8: 299-312, 2013
33. Sprague SM, Moe SM: Rebuttal: PTH - a particularly tricky hormone: Why measure it at all in kidney patients? Clin J Am Soc Nephrol 8: 321, 2013
34. Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM: Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 15: 2208-2218, 2004
35. Stehman-Breen CO, Sherrard DJ, Alem AM, Gillen DL, Heckbert SR, Wong CS, Ball A, Weiss NS: Risk factors for hip fracture among patients with end-stage renal disease. Kidney Int 58: 2200-2205, 2000
36. Mitterbauer C, Kramar R, Oberbauer R: Age and sex are sufficient for predicting fractures occurring within 1 year of hemodialysis treatment. Bone 40: 516-521, 2007
37. Goldsmith D, Kothawala P, Chalian A, Bernal M, Robbins S, Covic A: Systematic review of the evidence underlying the association between mineral metabolism disturbances and risk of fracture and need for parathyroidectomy in CKD. Am J Kidney Dis 53: 1002-1013, 2009
38. Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drüeke TB, Goodman WG: Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 350: 1516-1525, 2004
39. Parfitt AM: The hyperparathyroidism of chronic renal failure: A disorder of growth. Kidney Int 52: 3-9, 1997
40. Parfitt AM: Misconceptions (2): Turnover is always higher in cancellous than in cortical bone. Bone 30: 807-809, 2002
41. Leonard MB: A structural approach to skeletal fragility in chronic kidney disease. Semin Nephrol 29: 133-143, 2009
42. Jamal SA, Gilbert J, Gordon C, Bauer DC: Cortical pQCT measures are associated with fractures in dialysis patients. J Bone Miner Res 21: 543-548, 2006
43. Yajima A, Ogawa Y, Takahashi HE, Tominaga Y, Inou T, Otsubo O: Changes of bone remodeling immediately after parathyroidectomy for secondary hyperparathyroidism. Am J Kidney Dis 42: 729-738, 2003
44. Yajima A, Inaba M, Tominaga Y, Nishizawa Y, Ikeda K, Ito A: Increased osteocyte death and mineralization inside bone after parathyroidectomy in patients with secondary hyperparathyroidism. J Bone Miner Res 25: 2374-2381, 2010
45. Wada M, Ishii H, Furuya Y, Fox J, Nemeth EF, Nagano N: NPS R-568 halts or reverses osteitis fibrosa in uremic rats. Kidney Int 53: 448-453, 1998
46. Allen MR, Chen NX, Gattone VH 2nd, Chen X, Carr AJ, LeBlanc P, Brown D, Moe SM: Skeletal effects of zoledronic acid in an animal model of chronic kidney disease. Osteoporos Int 24: 1471-1481, 2013
47. Iwasaki Y, Kazama JJ, Yamato H, Fukagawa M: Changes in chemical composition of cortical bone associated with bone fragility in rat model with chronic kidney disease. Bone 48: 1260-1267, 2011
48. Tu X, Rhee Y, Condon KW, Bivi N, Allen MR, Dwyer D, Stolina M, Turner CH, Robling AG, Plotkin LI, Bellido T: Sost downregulation and local Wnt signaling are required for the osteogenic response to mechanical loading. Bone 50: 209-217, 2012
49. Takahashi T: Overexpression of Runx2 and MKP-1 stimulates transdifferentiation of 3T3-L1 preadipocytes into bone-forming osteoblasts in vitro. Calcif Tissue Int 88: 336-347, 2011